A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)

Ophthotech

Status and phase: Terminated; Phase 2

Conditions: Age-Related Macular Degeneration

Treatments: Drug: ranibizumab; Drug: Fovista®; Drug: aflibercept; Drug: bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02387957

OPH1006

Details and patient eligibility

About

To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

Full description

60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows:

• Avastin® 1.25 mg/eye (20 subjects)
• Lucentis® 0.5 mg/eye (20 subjects)
• Eylea® 2.0 mg/eye (20 subjects)

Subjects will be stratified by lesion size (≤2 DA vs. >2 DA).

Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.

When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).

Enrollment: 63 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects of either gender aged ≥ 50 years.
• Active subfoveal choroidal neovascularization (CNV) due to AMD.

Exclusion criteria

• Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
• Subjects with subfoveal scar or subfoveal atrophy
• Any ocular or periocular infection in the past twelve (12) weeks.
• History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

Fovista® plus bevacizumab

Experimental group

Description:

Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection

Treatment:

Drug: bevacizumab

Drug: Fovista®

Fovista® plus ranibizumab

Experimental group

Description:

Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection

Treatment:

Drug: Fovista®

Drug: ranibizumab

Fovista® plus aflibercept

Experimental group

Description:

Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection

Treatment:

Drug: aflibercept

Drug: Fovista®